Director, DSPV Data, Technology and Innovation

Insmed Incorporated•NJ Corporate Headquarters, NJ

7d•$185,000 - $252,500•Remote

About The Position

The Director, DSPV Data, Technology and Innovation is the business owner of Insmed's safety systems and is accountable for the Drug Safety & Pharmacovigilance (DSPV) data, technology and innovation strategy, roadmap and delivery. The role determines what technology DSPV needs, the order in which it is delivered, and whether delivered solutions are fit for purpose. The Director represents DSPV in enterprise technology, data and AI governance forums and partners with IT, the enterprise data platform team, Quality Assurance and the enterprise AI team. The position reports to the Senior Director, DSPV Business Strategy, Data & Technology. The role owns safety systems—including the safety database, signal and risk management tools, and safety reporting and analytics platforms—from business requirements and implementation through day-to-day use and eventual retirement. It leads vendor relationships, technology planning and project delivery, safety data migrations, analytics and reporting, and evaluation of AI opportunities for pharmacovigilance. It also supports validation, change control, regulatory compliance, inspections and audits, and coordinates with cross-functional groups so that safety systems and data meet business and regulatory needs. This is a fully remote role that may be performed from anywhere, with occasional travel for team meetings or events and minimal travel expected. The listed annual pay range is $185,000 to $252,500.

Requirements

Bachelor's degree in a scientific, computational, health-related or information systems discipline.
At least 10 years of experience in a biotech or pharmaceutical company, including at least 7 years working with pharmacovigilance systems, safety data or PV analytics.
Demonstrated experience as business owner, system owner or business lead for an industry-standard safety database, such as Oracle Argus, ArisGlobal LifeSphere/ARISg or Veeva Vault Safety.
Demonstrated experience implementing safety systems and leading or supporting safety data migrations, including data mapping, reconciliation and legacy-system decommissioning.
Demonstrated project management experience for technology projects, including scope, schedule, budget, resourcing and risk and issue management.
Demonstrated experience setting technology strategy and leading a multi-year program or portfolio of safety technology initiatives, with budget accountability and ability to influence senior leaders.
Experience leading, mentoring or developing direct or matrixed teams, including external contractors.
Experience managing technology vendors from the business side, including service-level performance, escalations and input to contracts and renewals.
Experience working with Quality Assurance on computer system validation, user acceptance testing and change control in a regulated GxP environment.
Working knowledge of MedDRA coding, E2B data standards and global PV regulatory requirements, including ICH E2A-E2F and GVP modules.
Sufficient understanding of modern AI and data systems—including data pipelines, integrations, model evaluation and ongoing performance monitoring—to work effectively with AI engineers, challenge proposals and set acceptance criteria.
Familiarity with enterprise data and business intelligence platforms such as Snowflake, Qlik, Power BI or Tableau, and working knowledge of SQL.

Nice To Haves

Advanced degree in a related field.
Practical experience with AI, machine learning, natural language processing or real-world evidence applications in pharmacovigilance or clinical development.
Familiarity with R, Python or SAS.

Responsibilities

Serve as business owner of Insmed's safety systems, including the safety database, signal and risk management tools, and safety reporting and analytics platforms.
Set and approve business requirements, configuration decisions, user access and release priorities for safety systems, making final business-side decisions when trade-offs are required.
Own business relationships with safety systems and technology vendors, including service-level performance, escalations, product roadmaps, releases, renewals, contracts and budgets in partnership with IT, Procurement and Legal.
Hold vendors and contractors accountable for delivery quality and timeliness and oversee contractors supporting DSPV systems activities.
Monitor safety-system capacity, performance and stability; raise risks to DSPV leadership; and maintain system inventories and business-side documentation for audits and inspections.
Own and annually refresh the DSPV technology roadmap with DSPV leadership and IT, and secure funding for its delivery.
Assess gaps in PV systems, tools and processes against regulatory requirements, portfolio growth and industry practice, and identify improvements.
Lead evaluation and selection of safety systems and technologies, including requirements, vendor demonstrations, requests for proposal and business cases.
Manage DSPV technology projects from initiation through completion, including scope, schedule, budget, resourcing, dependencies, risks, issues and leadership reporting.
Lead business-side safety data migrations, including mapping, reconciliation, verification and legacy-system decommissioning.
Lead business-side activities for new system implementation, including process design, user acceptance testing, training, cutover and post-implementation support.
Plan safety-system capability for product launches, label expansions and entry into new markets.
Define DSPV safety reporting and analytics needs, including compliance metrics, case-processing performance, product-level safety data and management reporting, using existing platforms wherever possible.
Own DSPV dashboard and report design and content, and maintain harmonized metric definitions with IT and the enterprise data platform team.
Enable signal detection, benefit-risk evaluation and patient exposure analysis by ensuring the appropriate data, tools and access are available in collaboration with Global Safety Leads and Medical Safety scientists.
Identify, prioritize and manage pharmacovigilance AI use cases, moving high-value use cases through structured pilots to clear decisions.
Set measurable pilot success criteria, data requirements, ongoing performance checks and human-review requirements; recommend whether to scale, adjust or stop based on evidence.
Maintain knowledge of PV technology and regulatory expectations for AI, including CIOMS Working Group XIV principles, FDA and EMA guidance, and applicable EU AI Act obligations, and share relevant information with DSPV.
Publish or present externally relevant pilot results and methods at industry forums and maintain records of DSPV evaluations and learning for potential regulatory discussions.
Act as the main DSPV point of contact for Insmed IT, translating business needs into requirements and user stories and communicating technical constraints, options and costs to DSPV.
Support Quality Assurance validation and change control with user requirements, risk assessments, test scripts and evidence, and change impact assessments.
Partner with the enterprise data platform team on shared infrastructure, including data feeds, data quality, access and reporting standards.
Partner with the enterprise AI team to bring DSPV use cases into its pipeline and ensure pharmacovigilance requirements are reflected in AI solution development, validation and monitoring.
Work with Regulatory Affairs, Clinical Development, Epidemiology and Biostatistics to support their safety systems and data requirements alongside DSPV's.
Support health authority inspections and audits related to safety systems, data and technology.
Contribute to DSPV SOPs, work instructions and training materials relating to systems, data and analytics.
Maintain knowledge of global PV requirements affecting systems and data, including EMA, FDA, PMDA, E2B and applicable ICH standards, and ensure Insmed systems keep pace.

Benefits

Comprehensive medical, dental and vision coverage and mental health support.
Annual wellbeing reimbursement and access to an Employee Assistance Program.
Generous paid time off policies.
Fertility and family-forming benefits and caregiver support.
Flexible work schedules with purposeful in-person collaboration.
401(k) plan with a competitive company match.
Annual equity awards and participation in the Employee Stock Purchase Plan.
Company-paid life and disability insurance.
Company Learning Institute resources, including LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections and networking opportunities.
Employee resource groups, service and recognition programs, and opportunities to connect, volunteer and give back.